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PRIMARY OBJECTIVE

• Evaluate the SVR rate of a combination therapy of daily interferon alfacon-1 (CIFN) at either Dose 1 or
  Dose 2 plus RBV compared to no treatment in HCV-infected patients who are nonresponders to previous PegIFN-alfa plus RBV therapy

SECONDARY OBJECTIVES

• Evaluate the safety and tolerability of combination therapy of daily interferon alfacon-1 at either
  Dose 1 or Dose 2 plus RBV compared to no treatment in HCV-infected patients who are nonresponders to previous PegIFN-alfa plus RBV therapy



• Evaluate the proportion of patients with abnormal baseline serum alanine aminotransferase (ALT) levels that are normal at:
  • Week 24
  • Week 48
  • Weeks 48 and 72

EFFICACY AND SAFETY ENDPOINTS:

PRIMARY EFFICACY ENDPOINT

• Proportion of patients with SVR rate defined as the absence of detectable HCV RNA in serum by bDNA/TMA assay at weeks 68 and 72

SAFETY ENDPOINTS

• Proportion of patients with
  • Adverse events
  • Abnormal laboratory safety tests
  • BDI-II score ≥ 29
  • Dose reductions, interruptions, and discontinuations
• Proportion of patients randomized to the treatment arms who develop anti-interferon alfacon-1 (anti-CIFN) and neutralizing antibodies